Orange Book product · Brand (NDA)
DENAVIR
PENCICLOVIR
Brand (NDA)NDA 020629TE ABRX MYLAN
At a glance
Sep 24, 1996
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 24, 1996
30 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
PENCICLOVIR
Strength
1%
Dosage form
CREAM
Route
TOPICAL
TE code
AB
Application
NDA 020629
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
